Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma
Summary
The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.
Detailed description
The safety and tolerability of the combination of ipilimumab and axitinib will be tested in advanced melanoma patients who are intolerable/refractory to anti-PD-1/PD-L1 therapy and have not previously received treatment with ipilimumab.
Arms & interventions
- DrugIpilimumab
Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.
- DrugAxitinib
Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)
Outcome measures
Primary
Overall Response Rate
Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per irRECIST and RECIST v1.1 criteria.
Time frame: Up to 24 months
Secondary
Progression Free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Clinical Benefit Rate
Time frame: Up to 12 months
Eligibility criteria
Study locations (1)
Moffitt Cancer Center
Tampa, Florida, 33612